India Overrules Bayer, Allowing Generic Drug
India’s government on Monday authorized a drug manufacturer to make and sell a generic copy of a patented Bayer cancer drug, saying that Bayer charged a price that was unaffordable to most of the nation.
The decision by the official in charge — the controller general of patents, designs and trademarks — marked the first granting of a so-called compulsory license of a patented drug in India. Legal experts and patient advocates said it could open the door to a flood of other compulsory licenses in India and possibly in other developing countries, ushering in a new supply of cheap generic pharmaceuticals.
According to the decision, Bayer must license the drug Nexavar, or sorafenib, to Natco Pharma, an Indian company. In exchange, Natco must pay Bayer a 6 percent royalty on its net sales and has to sell the drug for 8,800 rupees ($176) a month, about 3 percent of the 280,000 rupees that Bayer charges for it in India. Natco’s drug is for use only in India, the decision said.
Nexavar, a tablet, is used to treat advanced kidney cancer and liver cancer and has been shown to extend lives by a median of about three months. It was used to treat fewer than 200 Indians in 2011.
Oliver Renner, a spokesman for Bayer at its headquarters in Germany, said the company was disappointed by the decision and was “evaluating our legal options to continue to defend our intellectual property.”
Advocates for cheaper generic medicines cheered the decision, which they said could provide a model in developing countries, where most people cannot afford to pay retail prices for many important medicines and do not have access to insurance plans that would pay for them.
“I think it’s the way forward,” said Shamnad Basheer, a professor at the West Bengal National University of Juridical Sciences, who has written about the case extensively. “In the entire debate about patents, this is the middle path.”